In applicants' own international patent application WO 03/015860 A1 (“Micro Needles and Method of Manufacture Thereof”) there is disclosed a method of manufacturing hollow micro-projections having side openings. Such projections are suitable for use as micro needles for e.g. injection through the skin of medicaments.
The method disclosed in said WO publication is based on micro machining of e.g. silicon substrates.
In an article by A. E. Guber et al (“Polymer Micro Needles With Through-going Capillaries”, in Micro Total Analysis Systems 2001, eds. Ramsey and van den Berg, pp 155-156), there is disclosed a method of making micro-needles by micro replicating. A first mold insert having a 1 mm deep conic hole, and a second mold insert, carrying a tin needle fitting in the mold are used. The first mold insert is made by a combination of micro machining and electroforming. The needle on the second mold insert is made by grinding tungsten carbide, and inserting the needle into a brass body. The product of the disclosed process is a conical projection (needle) with an inner lumen and an opening at the tip of the cone, the opening being made by laser drilling.
These prior art devices and methods, while contributing to the development of the technology, still suffer from some drawbacks. The device according to WO 03/015860 A1 requires bulk etching of material, which means that the cost of manufacture is affected by the use of excess material, i.e. large quantities of the bulk material must be removed to yield an array of microneedles. This may result in long fabrication and process times and thus in high cost.
The device disclosed by Gruber et al eliminates the use of excess material by using a molding technique, but instead require fairly complicated mold making technology, the opening requires an additional step (laser drilling), and above all, it dose not enable manufacture of side-opened needles.
In U.S. patent application Ser. No. 10/417,541 (US 2003/0208138 A1, published Nov. 6, 2003) there is disclosed a method of micro-replicating to provide micro-needles. However, the needles obtained are conical and have an opening at the apex of the cone, and are therefore unsuitable for certain applications.